BeiGene (BGNE) Announces China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy.

“With today’s approvals, tislelizumab is now available in China in five indications covering lung, liver, bladder, and lymphoma, and is becoming an important immunotherapy in the world’s most populous country,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. “This remarkable achievement, which began approximately 18 months ago with tislelizumab’s initial approval, was made possible through BeiGene’s integrated global clinical development approach. We hope to make tislelizumab available broadly in China through our science-based commercial team and globally through our collaboration with Novartis, in furtherance of our goal of expanding access to innovative, quality cancer treatments for more people worldwide.”

“We are pleased about the concurrent approvals for tislelizumab in China – in first-line non-squamous NSCLC following the previous approval for NSCLC patients with squamous histology earlier this year, and in second- or third-line HCC, which was based on the results from the largest global single-arm pivotal trial of any anti-PD-1 antibody in this indication,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “The pivotal clinical program of tislelizumab has seen tremendous progress lately, including two positive Phase 3 trials, one in esophageal cancer and the other in nasopharyngeal cancer. We credit our accomplishment to the dedication of our BeiGene team, and most importantly, the trust from participating patients and their loved ones, as well as investigators leading these clinical trials.”

NMPA Approval in First-Line Advanced Non-Squamous NSCLC

“NSCLC comprises the most common form of lung cancer, although diagnoses are usually delayed with most patients diagnosed at advanced stage. In the Phase 3 RATIONALE 304 trial, tislelizumab in combination with pemetrexed and platinum chemotherapy demonstrated a clinically significant improvement in progression-free survival along with a high response rate, and was generally well-tolerated for treatment-naïve patients with advanced non-squamous NSCLC,” commented Shun Lu, M.D., Ph.D., Professor of Shanghai Chest Hospital at Jiao Tong University and lead investigator for the trial. “I believe that this approval could help meet the significant demand in the front-line care of NSCLC, and I also look forward to the overall survival data readout.”

The approval of tislelizumab for the first-line treatment of patients with advanced non-squamous NSCLC was supported by clinical results from a Phase 3 trial (NCT03663205) of tislelizumab in combination with pemetrexed and platinum chemotherapy (either carboplatin or cisplatin) in patients with stage IIIB or stage IV non-squamous NSCLC, compared to pemetrexed and platinum alone. A total of 334 patients in China were enrolled in the trial, randomized 2:1 to either the tislelizumab and chemotherapy arm or the chemotherapy arm. As announced in April 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. The safety profile of tislelizumab in combination with chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified. The results of the interim analysis of the trial were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September 2020.

NMPA Approval in Second- or Third-Line HCC

The NMPA conditional approval of tislelizumab in patients with HCC who have received at least one systemic therapy is based on clinical results from a single-arm, open-label, multicenter, global pivotal Phase 2 trial (NCT03419897) conducted in 249 patients from eight countries and regions in Asia and Europe, including 138 patients (55.4%) who received one line of prior systemic therapy and 111 patients (44.6%) who received at least two lines of prior therapies. Of all the patients enrolled in the trial, the median age was 62 years and 63.9% of patients had history of viral hepatitis, with hepatitis B accounting for the majority (51.4%) followed by hepatitis C (14.5%).

“Hepatocellular carcinoma is a difficult-to-treat primary liver cancer, most commonly found in those living with chronic liver diseases, such as hepatitis B and C. Based on the encouraging efficacy and safety results in patients with advanced liver cancer from this trial, tislelizumab has the potential to bring long-term survival benefits to patients with second- or third-line HCC in China,” commented Zhenggang Ren, M.D., Ph.D., Professor at Zhongshan Hospital, Fudan University, and the trial’s leading investigator in China.

With a median follow-up time of 12.4 months, objective response rate (ORR) as assessed by IRC per RECIST v1.1 was 13.3% (95% CI: 9.3, 18.1), including three complete responses (CRs); disease control rate (DCR) was 53.0% (95% CI: 46.6, 59.3); among patients who achieved a CR or partial response (PR), 90.4% (95% CI: 73.1, 96.8) and 79.2% (95% CI: 59.3, 90.2) of them sustained response at six months and 12 months, respectively. Median overall survival (OS) was 13.2 months (95% CI: 10.8, 15.0) and PFS was 2.7 months (95% CI: 1.4, 2.8).

The safety profile of tislelizumab as a monotherapy in the label in China was based on 1,183 patients who received tislelizumab as a monotherapy in five clinical trials, including the pivotal Phase 2 trial in HCC. The most common adverse reactions (≥10%) were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, rash, and fatigue. Grade ≥3 adverse reactions occurred in 17.3% of patients, with the most common (≥1%) being AST increased, ALT increased, gamma-glutamyltransferase increased, anemia, pneumonitis, and lung infection. For tislelizumab as a monotherapy, the most common immune-mediated adverse reactions were immune-mediated pneumonitis, diarrhea and colitis, hepatitis, nephritis, endocrinopathies (hypothyroidism, hyperthyroidism, thyroiditis, adrenocortical insufficiency, and hyperglycemia and Type 1 diabetes mellitus), skin adverse reactions, pancreatitis, myocarditis, and myositis.

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